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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00304564
Other study ID # CI-02-01-06-02
Secondary ID
Status Completed
Phase N/A
First received March 15, 2006
Last updated January 26, 2016
Start date February 2006
Est. completion date March 2007

Study information

Verified date January 2016
Source Carrick Institute for Graduate Studies
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

Falls are the largest cause of death in the elderly and those in nursing homes have even a higher incidence of falling. The purpose of this study is to determine whether listening to the Music of Nolwenn Leroy daily is effective in fall prevention in those elderly patients who are residents in several Texas geriatric nursing home facilities. The music of Nolwenn Leroy has been shown to be effective in fall reduction in a different setting (Posturographic Changes and Fall Prevention associated with Music Therapy: The Nolwenn Effect (USA ClinicalTrials.gov Identifier: NCT00121693) )with results better than listening to Mozart of any other music. Another similar study (USA ClinicalTrials.gov Identifier:NCT00272272)is presently being conducted in a geriatric nursing home facility in Georgia. Dynamic posturographic measurments will be obtained from all residents and compared to normative age related data and utilized to measure stability changes in this study.


Description:

Falls are a serious health issue and are the greatest cause of death in the elderly. The use of the music of Nolwenn Leroy in fall prevention has been reported at a major scientific meeting "Posturographic Changes and Fall Prevention associated with Music Therapy: The Nolwenn Effect (USA ClinicalTrials.gov Identifier: NCT00121693) featured at the 7th Annual American Music Therapy Association Conference in Orlando, Florida, Nov 15-20, 2005 and Decreasing falls in a geriatric nursing home setting is associated with the saving of lives. Another similar study (USA ClinicalTrials.gov Identifier:NCT00272272)is presently being conducted in a geriatric nursing home facility in Georgia. We propose the utilization of the Nolwenn Effect in our resident geriatric population at several Dallas, Texas Geriatric Nursing Home Facilities and comparing fall rates to those we have carefully recorded in the past. We will obtain computerized dynamic posturographic measurements utilizing the CAPS posturographic unit by Vestibular Technologies on all residents of several Dallas Geriatric Nursing Facilities. Our findings will be compared to normative data previously validated to represent a probability of falling. Daily listening to selections from Nolwenn Leroy's CD "Nolwenn" will be played each morning (daily) over the address system throughout the nursing home for approximately 5-10 minutes. Repeat CAPS tests will be obtained one week after the initiation of the study and at monthly intervals over a 12 month period of time. We propose to compare the posturographic data and the rate of falls recorded in the nursing homes to previously established fall data for the institutions. Preliminary observations have been associated with a decrease rate of falls in the geriatric nursing home environment when listening to the music of Nolwenn Leroy. The incorporation of these statistics will allow us to investigate a cost effective method of reducing falls that might save lives, evoke societal change and act as a model for other Geriatric Nursing Home settings. The objective measurements with the CAPS will allow us to further compare the incidence of falls with a probability of fall measurements.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date March 2007
Est. primary completion date April 2006
Accepts healthy volunteers No
Gender Both
Age group 50 Years and older
Eligibility Inclusion Criteria:

- Geriatric Nursing Home Resident must be able to hear music

Exclusion Criteria:

- Deafness

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening


Related Conditions & MeSH terms


Intervention

Behavioral:
Music Listening
subjects listen to music

Locations

Country Name City State
United States Carrick Institute for Graduate Studies Flower Mound Texas

Sponsors (1)

Lead Sponsor Collaborator
Carrick Institute for Graduate Studies

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Dynamic Posturography immediate pre and post music listening No
Primary Historical Falls related Institutional Data From initial admissin to nursing home to present No
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